Accutest Drug Test Cassette ER 11 CLIA Waived – 25/Box (AMP / BAR / BZO / COC / THC / MDMA / OPI / OXY / PCP / PPX / TCA)
$350.00
FDA 510(k) Cleared
Professional Use
25 tests per box$14.00 per test
Professional 11-panel urine drug-test cassette for the simultaneous qualitative screening of AMP, BAR, BZO, COC, THC, MDMA, OPI, OXY, PCP, PPX and TCA. Read results at 5 minutes.
- Screens 11 drugs and drug classes in one cassette
- Includes OPI at a 300 ng/mL cutoff plus a separate OXY assay at 100 ng/mL
- On-board positive and negative procedural control regions
- Add three drops to each sample well; read at 5 minutes and not after 15 minutes
| 1-5 | 6-10 | 11+ |
| $350.00 | $322.00 | $304.50 |
ACCUTEST MultiDrug ER 11 Cassette Overview
The ACCUTEST MultiDrug ER 11, reference DS135, is a professional CLIA-waived urine cassette for the simultaneous qualitative screening of 11 drugs and drug classes. The single-use, visually interpreted device contains four immunochromatographic strips and on-board positive and negative procedural control regions. Results are read at 5 minutes, and each box contains 25 test devices with disposable droppers and procedure materials.
FDA 510(k) Cleared
Professional Use
25 Tests per Box
Features and Benefits
Product Details
DS135
DTK-106110
K041685
25 Tests per Box
| Specification | Details |
|---|---|
| Brand | ACCUTEST |
| Manufactured for | Jant Pharmacal Corporation |
| FDA applicant | ACON Laboratories, Inc. |
| Test format | Single-use, four-strip, 11-panel urine cassette |
| Test method | Competitive-binding lateral-flow immunochromatographic assay |
| Sample | Human urine |
| Sample volume | Three full drops, approximately 100 µL, into each of four sample wells |
| Result type | Preliminary qualitative screening result |
| Read time | Read at 5 minutes; do not interpret after 15 minutes |
| Intended use | Professional in vitro diagnostic use, including point-of-care settings |
| Regulatory status | CLIA waived; FDA 510(k) cleared under K041685 |
| Storage | 36–86°F (2–30°C); keep sealed and do not freeze |
Drug Panel and Cutoff Levels
The ACCUTEST MultiDrug ER 11 screens the following drugs and drug classes in human urine at the listed cutoff concentrations.
| Drug or Drug Class | Abbreviation | Cutoff |
|---|---|---|
| Amphetamine | AMP | 1,000 ng/mL |
| Barbiturates | BAR | 300 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine metabolite | COC | 300 ng/mL |
| Marijuana metabolite | THC | 50 ng/mL |
| Ecstasy | MDMA | 500 ng/mL |
| Opiates | OPI | 300 ng/mL |
| Oxycodone | OXY | 100 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| Propoxyphene | PPX | 300 ng/mL |
| Tricyclic antidepressants | TCA | 1,000 ng/mL |
This test provides a preliminary qualitative screening result only. It does not determine impairment, administration route or drug concentration in urine. A more specific analytical method must be used to confirm a preliminary positive result; the package insert identifies GC/MS as the preferred confirmatory method.
How to Perform the Test
Understanding the On-Board Controls
Understanding the Test Results
Quality Control
The device includes on-board positive and negative procedural control regions. The package insert states that these internal controls satisfy the daily control-testing requirement when used with a comprehensive laboratory quality-assurance program. External positive and negative controls are recommended with each new lot or shipment, for each new operator, monthly as a storage-condition check, when problems are suspected and as otherwise required by the laboratory’s quality system.
Storage and Handling
Instructions and Regulatory Documents
Frequently Asked Questions
What does the ACCUTEST MultiDrug ER 11 screen for?
It screens human urine for amphetamine, barbiturates, benzodiazepines, cocaine metabolite, marijuana metabolite, MDMA, opiates, oxycodone, phencyclidine, propoxyphene and tricyclic antidepressants at the cutoff concentrations listed above.
Is the ACCUTEST ER 11 CLIA waived?
Yes. The product-specific package insert identifies the device as CLIA waived. Laboratories must have the appropriate certificate of waiver and follow the manufacturer’s instructions to perform it as a waived test.
Is this test intended for over-the-counter use?
No OTC claim is included for this configuration. The package insert and FDA decision summary identify professional in vitro diagnostic and point-of-care use.
Does this panel use OPI 300 or OPI 2000?
This exact ER 11 configuration uses the 300 ng/mL opiates cutoff. It also includes a separate oxycodone assay at a 100 ng/mL cutoff.
How quickly are results available?
Read the test at 5 minutes. Do not interpret results after 15 minutes.
How much urine is required?
Add three full drops, approximately 100 µL, to each of the four sample wells using the included dropper.
What do the NEG and POS control regions mean?
A valid test has a visible line in the NEG region and no visible line in the POS region. No NEG line and/or a visible POS line makes the result invalid.
What does a faint drug-test line mean?
When the control pattern is valid, any visible line beside a drug abbreviation is interpreted as negative regardless of the test line’s color intensity.
Does a preliminary positive result require confirmation?
Yes. A preliminary positive screening result must be confirmed using a more specific analytical method. The package insert identifies GC/MS as the preferred confirmatory method.
How many tests are included?
Each box contains 25 single-use test cassettes with disposable droppers, a package insert and a procedure card.
Additional information
| Weight | 2 lbs |
|---|---|
| Dimensions | 8 × 5 × 4 in |
